BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER

    MDR report key: 7057774 · Received November 24, 2017

    Report

    Report Number
    8031673-2017-00123
    Event Type
    Malfunction
    Date Received
    November 24, 2017
    Date of Event
    October 27, 2017
    Report Date
    December 29, 2017
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: ON (B)(6) 2017 A FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THE FLOW RATE WAS 1.34 ML/MIN AND THE RETENTION TIME WAS 0.61 MINUTES. THE FSE REPLACED THE UPTAKE CHECK VALVE AND THE PURGE CHECK VALVE AND ADJUSTED THE FLOW RATE TO 1.08 ML/MIN (1.0 ML/MIN +/- 0.05). THE FSE REPLACED THE PUMP DIAPHRAGM. THE FSE RAN CALIBRATION, QUALITY CONTROLS, AND PRECISION; ALL PASSED. THE INSTRUMENT WAS RUNNING WITHIN SPECIFICATIONS. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL (B)(4) FROM 27-SEP-2016 THROUGH (B)(6) 2017. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE G8 OPERATOR'S MANUAL UNDER CHAPTER 1, INTRODUCTION AND APPLICATION, STATES THE FOLLOWING: THE TIME FROM INJECTION OF THE SAMPLE TO THE TIME THE SPECIFIC PEAK ELUTES OFF THE COLUMN IS CALLED RETENTION TIME. THE TOSOH AUTOMATED GLYCOHEMOGLOBIN ANALYZER HLC-723G8 SOFTWARE HAS BEEN WRITTEN SO THAT EACH OF THE EXPECTED FRACTIONS HAS A WINDOW OF ACCEPTABLE RETENTION TIMES. IF THE DESIGNATED PEAK FALLS WITHIN THE EXPECTED WINDOW, THE CHROMATOGRAM PEAKS WILL BE PROPERLY IDENTIFIED. WHEN A PEAK ELUTES AT A RETENTION TIME NOT WITHIN A SPECIFIED WINDOW, AN UNKNOWN PEAK (P00) RESULTS. IF MORE THAN ONE PEAK ELUTES AT TIMES NOT SPECIFIED BY THE SOFTWARE WINDOWS, EACH IS GIVEN A SEQUENTIAL P0X TITLE. IN ORDER TO KEEP THE PEAKS WITHIN THEIR APPROPRIATE WINDOWS, IT MAY BE NECESSARY TO CHANGE HOW FAST OR SLOW THE BUFFERS ARE MOVING THROUGH THE SYSTEM BY CHANGING THE PUMP FLOW RATE. THE G8 TRAINING MANUAL UNDER LESSON 8, COLUMN REPLACEMENT, STATES THE FOLLOWING: ADJUSTING THE FLOW RATE - HOW AND WHY ON THE TOSOH AUTOMATED GLYCOHEMOGLOBIN ANALYZER HLC-723G8; VARIANT ANALYSIS MODE IT MAY BE NECESSARY TO ADJUST THE FLOW RATE BECAUSE EITHER UNIDENTIFIABLE PEAKS APPEAR ON ALL THE CHROMATOGRAMS OR THE AVERAGE RETENTION TIME FOR VARIOUS PEAKS HAS CHANGED SIGNIFICANTLY. THE FLOW RATE IS CHANGED BY CHANGING THE FLOW FACTOR IN THE INSTRUMENT. IF MOST CHROMATOGRAMS EXHIBIT UNIDENTIFIABLE PEAKS FOR NO APPARENT REASON AND THE AVERAGE RETENTION TIME (RT) FOR SA1C VARIES SIGNIFICANTLY FROM THE IDEAL RT OF 0.59, THE PRESENCE OF THESE PEAKS CAN USUALLY BE ELIMINATED BY CHANGING THE FLOW RATE. THE FLOW FACTOR IS GENERALLY 1.00 ML/MIN. THE FLOW FACTOR SHOULD ONLY BE ADJUSTED +/- 0.05 OF THE DEFAULT FACTORY SETTING. LESSON 5, INTERPRETATION RESULTS, STATES THE FOLLOWING: THE RETENTION TIME IS ONE OF THE MOST IMPORTANT ITEMS TO LOOK AT WHEN INTERPRETING RESULTS. THE HBA1C RETENTION TIME SHOULD BE BETWEEN 0.57 AND 0.61. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO THE UPTAKE CHECK VALVE AND PURGE CHECK VALVE.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED A RETENTION TIME OF 0.64 MINUTES (ACCEPTABLE RANGE OF 0.57 - 0.61 MINUTES) ON PATIENT SAMPLES WITH THE G8 INSTRUMENT. THE CUSTOMER REPORTED THAT RETENTION TIME ON QUALITY CONTROLS WAS WITHIN RANGE. THE CUSTOMER REPORTED THAT THE FLOW FACTOR WAS 1.3 ML/MIN AND THE COLUMN INJECTION COUNT WAS 1600 (MAXIMUM OF 2500 RECOMMENDED). THE CUSTOMER REPORTED HAVING TO ADJUST THE FLOW RATE SEVERAL TIMES, BUT RETENTION TIME CONTINUED TO BE TOO FAST. THERE IS NO INFORMATION REGARDING HBA1C RESULTS BEFORE AND AFTER ADJUSTMENT OF FLOW FACTOR. THE CUSTOMER WAS UNABLE TO RUN PATIENT SAMPLES ON HEMOGLOBIN A1C (HBA1C). ON 26-OCT-2017 A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR HBA1C. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

    Additional Manufacturer Narrative · 1

    (B)(4), PER EXEMPTION NUMBER E2017013. REPORT SOURCE: UNDER THE ABOVE SECTION "USER FACILITY" WAS INCORRECTLY SELECTED. THE ONLY REPORT SOURCE IS "HEALTH PROFESSIONAL".

    Description of Event or Problem · 1

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836750 TOSOH HLC-723G8 ANALYZER G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1